9001-2008 to 9001-2015 to IATF 16949

(1)

0. Introduction

0.4 Goal of this Technical Specification

1.1 General 1.2 Application

2. Normative references 3. Terms and definitions

3.1 Terms and definitions for the automotive industry 3.1

4. Quality Management System

4.1 General Requirements

4.1.1 General requirements - Supplemental 4.4.1.1

4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.3.1 Engineering specifications 7.5.3.2.1 4.2.4 Control of Records 4.2.4.1 Records retention 7.5.3.2.1 5. Management Responsibility 5.1 Management Commitment 5.1.1 Process efficiency 5.1.1.2 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning ISO 9001:2008 - ISO/TS 16949:2009 IATF 16949:201 6

(2)

ISO 9001:2008 - ISO/TS 16949:2009

IATF 16949:201

6

5.4.1.1 Quality Objective - supplemental 6.2.2.1

5.4.2 Quality Management System Planning 5.5 Responsibility, Authority, and Communication

5.5.1 Responsibility and Authority

5.5.1.1 Responsibility for quality 5.3.1, 5.3.2

5.5.2 Management Representative

5.5.2.1 Customer representative Removed

5.5.3 Internal Communications 5.6 Management Review 5.6.1 General

5.6.1.1 Quality management system performance 9.3.1.1 5.6.2 Review Input

5.6.2.1 Review Input - supplemental 9.3.2.1

5.6.3 Review Output 6. Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.2.1 General

6.2.2 Competence, Training, and Awareness

6.2.2.1 Product design skills 7.2.1

6.2.2.2 Training 7.2.1

6.2.2.3 Training on the job 7.2.2 6.2.2.4 Employee motivation and empowerment 7.3.2

6.3 Infrastructure

6.3.1 Plant, facility and equipment planning 7.1.3.1 6.3.2 Contingency plans 6.1.2.3

(3)

ISO 9001:2008 - ISO/TS 16949:2009 IATF 16949:201 6 6.4.2 Cleanliness of premises 7.1.4.1 7. Product Realization

7.1 Planning of Product Realization

7.1.1 Planning of product realization - supplemental 8.1.1 7.1.2 Acceptance criteria

7.1.3 Confidentiality 8.1.2 7.1.4 Change control

7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

7.2.1.1 Customer-designated special characteristics

7.2.2 Review of Requirements Related to the Product

8.2.3.1.1

7.2.3 Customer Communication

7.2.3.1 Customer Communication - supplemental 8.2.1.1

7.3 Design and Development

7.3.1 Design and Development Planning

7.3.1.1 Multidisiplinary approach 8.3.2.1

7.3.2 Design and Development Inputs

7.3.2.1 Product design input 8.3.3.1 7.3.2.2 Manufacturing process design input 8.3.3.2 7.3.2.3 Special characteristics 8.3.3.3 6.4.1 Personal safety to achieve conformity to product

requirements

See 7.1.4 NOTE

7.2.2.1 Review of Requirements Related to the Product - supplemental

(4)

ISO 9001:2008 - ISO/TS 16949:2009

IATF 16949:201

6

7.3.3.1 Product design outputs - supplemental 8.3.5.1 7.3.3.2 Manufacturing process design output 8.3.5.2

7.3.4 Design and Development Review

7.3.4.1 Monitoring 8.3.4.1

7.3.5 Design and Development Verification 7.3.6 Design and Development Validation

8.3.4.2 7.3.6.2 Prototype programme 8.3.4.3 7.3.6.3 Product approval process 8.3.4.4

7.3.7 Control of Design and Development Changes 8.3.6.1

7.4 Purchasing

7.4.1 Purchasing Process

7.4.1.1 Statutory and regulatory conformity 8.4.2.2 8.4.2.3 7.4.1.3 Customer-approved sources 8.4.1.3

7.4.2 Purchasing Information

7.4.3 Verification of Purchased Product

7.4.3.1 Incoming product conformity to requirements 8.6.4 7.4.3.2 Supplier monitoring 8.4.2.4

7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

7.5.1.1 Control plan 8.5.1.1 7.5.1.2 Work instructions 8.5.1.2 7.3.6.1 Design and Development Validation -

supplemental

7.4.1.2 Supplier quality management system development

(5)

ISO 9001:2008 - ISO/TS 16949:2009

IATF 16949:201

6

7.5.1.3 Verification of job setups

7.5.1.4 Preventive predictive maintenance 8.5.1.5 7.5.1.5 Management of production tooling 8.5.1.6 7.5.1.6 Production scheduling 8.5.1.7 7.5.1.7 Feedback of information from service 8.5.5.1 7.5.1.8 Service agreement with customer 8.5.5.2

7.5.3 Identification and Traceability

7.5.3.1 Identification and Traceability - supplemental 8.5.2.1

7.5.4 Customer Property

7.5.4.1 Customer owned production tooling ISO 8.5.3

7.5.5 Preservation of Product

7.5.5.1 Storage and inventory 8.5.4.1

7.6 Control of Monitoring and Measuring Equipment

8.5.1.3, 8.5.1.4

7.5.2 Validation of Processes for Production and Service Provision

7.5.2.1 Validation of Processes for Production and Service Provision - supplemental

8.5.5.1, 8.5.5.2

(6)

ISO 9001:2008 - ISO/TS 16949:2009

IATF 16949:201

6

7.6.1 Measurement system analysis 7.1.5.1.1

7.6.2 Calibration/verification records 7.1.5.2.1

7.6.3 Laboratory requirements 7.1.5.3

7.6.3.1 Internal laboratory 7.1.5.3.1

7.6.3.2 External laboratory 7.1.5.3.2 8. Measurement, Analysis, and Improvement

8.1 General

8.1.1 Identification of statistical tools 9.1.1.2 8.1.2 knowledge of basic statistical concepts 9.1.1.3

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

8.2.1 Customer Satisfaction- supplemental 9.1.2.1

8.2.2 Internal Audit

8.2.2.1 Quality management system audit 9.2.2.2 8.2.2.2 Manufacturing process audit 9.2.2.3 8.2.2.3 Product audit 9.2.2.4 8.2.2.4 Internal audit plans 9.2.2.1 8.2.2.5 Internal auditor qualifications 7.2.3, 7.2.4

8.2.3 Monitoring and Measurement of Processes

9.1.3.1

8.2.4 Monitoring and Measurement of Product

8.2.4.1 Layout inspection and functional testing 8.6.2 8.2.4.2 Appearance items 8.6.3 8.2.3.1 Monitoring and measurement of manufacturing processes

(7)

ISO 9001:2008 - ISO/TS 16949:2009

IATF 16949:201

6

8.3 Control of Nonconforming Product

8.3.1 Control of Nonconforming Product - supplemental

8.3.2 Control of reworked product 8.7.1.4 8.3.3 Customer information 8.7.1.6 8.3.4 Customer waiver

8.4 Analysis of Data 8.5 Improvement

8.5.1 Continual Improvement

8.5.1.1 Continual improvement for the organization 10.3.1 8.5.2.2 Manufacturing process improvement 10.3.1

8.5.2 Corrective Action

8.5.2.1 Problem solving 10.2.3

8.5.2.2 Error-proofing 10.2.4

8.5.2.3 Corrective action impact 8.5.2.4 Rejected product test/analysis

8.5.3 Preventive Action

ANNEX A: CONTROL PLAN A.1 Phases of the control plan A.2 Elements of the control plan

8.7.1.2, 8.7.1.3 8.7.1.1, 8.7.1.7 10.2.5, 10.2.6

(8)

ISO 9001:2015

0. Introduction 1. Scope

4.3 Determining the scope of the quality management system

2. Normative references 3. Terms and definitions 4. Context of the organization 4.1

4.2 4.3

4.4 Quality management system and its processes 4.4.1 7.5 Documented information 7.5.1 General -7.5.2 7.5.3.1 and 7.5.3.2 7.5 Documented Information 7.5 Documented Information 5. Leadership

5.1 Leadership and commitment 5.1.1 General 5.1.2 Customer focus 5.2 Quality policy 5.2.1 5.2.2 6. Planning

(9)

ISO 9001:2015

6.2.1 and 6.2.2

6.3 Planning of change

5.3 Organizational roles, responsibilities and authorities

-7.4 Communication 9.3 Management Review 9.3.1 Management Review

9.3.2 Management Review Inputs

9.3.3 Management Review Outputs 7.1 Resources 7.1 Resources 7.1.1 General 7.1.2 People 7.2 Competence 7.3 Awareness 7.1.3 Infrastructure

(10)

ISO 9001:2015

8. Operation

8.1 Operational planning and control

8.2 Requirements for products and services

8.2.2 Determining of requirements related to products and services

8.2.3 Review of requirements related to products and services 8.2.3.1

8.2.3.2

8.2.4 Changes to requirement for products and services

8.2.1 Customer communication

8.3 Design and development of products and services 8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development inputs

(11)

ISO 9001:2015

8.3.4 Design and development controls 8.3.4 Design and development controls 8.3.4 Design and development controls

8.3.6 Design and development changes

8.4 Control of externally provided processes, products and services 8.4.1 General

8.4.3 Information for external providers

8.4.2 Type and extent of control and 8.6 Release of products and services

8.5 Production and service provision

(12)

ISO 9001:2015

8.5.5 Post Delivery Activities

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers 8.5.4 Preservation

7.1.5 Monitoring and measuring resources 7.5.1.1 General

7.1.5.2 Measurement traceability

7.1.6 Organizational knowledge 7.2 Competence

(13)

ISO 9001:2015

7.3 Awareness

9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General

9.1.1 General

9.1.2 Customer satisfaction

9.2 Internal Audit 9.2.1 and 9.2.2

9.1.3 Analysis and evaluation

(14)

ISO 9001:2015

8.7 Control of nonconforming outputs 8.7.1

8.7.2 The organization shall retain documented information:

9.1.3 Analysis and evaluation 10. Improvement

10.1 General

10.3 Continual Improvement

10.2 Nonconformity and corrective action 10.2.1 and 10.2.2

6.1 Actions to address risks and opportunities 6.1.1 and 6.1.2

(15)

IATF 16949:2016

See ISO 9001:2015 requirements See ISO 9001:2015 requirements

1.1 Scope - Automotive supplemental to ISO 9001:2015 See ISO 9001:2015 requirements

4.3.1 Determining the scope of the quality management system - Supplemental 4.3.2 Customer specific requirements

See ISO 9001:2015 requirements 2.1 Normative and informative references See ISO 9001:2015 requirements

3.1 Terms and definitions for the automotive industry Blank

See ISO 9001:2015 requirements See ISO 9001:2015 requirements See ISO 9001:2015 requirements Blank

See ISO 9001:2015 requirements

4.4.1.1 Conformance of products and processes 4.4.1.2 Product safety

Blank

7.5.1.1 Quality management system documentation See ISO 9001:2015 requirements

See ISO 9001:2015 requirements 7.5.3.2.1 Record retention 7.5.3.2.2 Engineering specifications See Above See Above Blank Blank

See ISO 9001:2015 requirements 5.1.1.1 Corporate responsibility

5.1.1.2 Process effectiveness and efficiency 5.1.1.3 Process owners

See ISO 9001:2015 requirements Blank

See ISO 9001:2015 requirements See ISO 9001:2015 requirements See ISO 9001:2015 requirements

(16)

IATF 16949:2016

6.2.2.1 Quality objectives and planning to achieve them - supplemental See ISO 9001:2015 requirements

5.3.1 Organizational roles, responsibilities and authorities - supplemental

5.3.2 Responsibility and authority for product requirements and corrective actions See ISO 9001:2015 requirements

Blank

See ISO 9001:2015 requirements 9.3.1.1 Management Review - supplemental See ISO 9001:2015 requirements

9.3.2.1 Management Review Inputs - supplemental See ISO 9001:2015 requirements

9.3.3.1 Management Review Outputs - supplemental Blank

Blank

See ISO 9001:2015 requirements See ISO 9001:2015 requirements See ISO 9001:2015 requirements 7.2.1 Competence - supplemental 7.2.2 Competence - on-the-job training 7.2.3 Internal auditor competency 7.2.4 Second-party auditor competency See ISO 9001:2015 requirements 7.3.1 Awareness - supplemental

7.3.2 Employee motivation and empowerment

7.1.3.1 Plant, facility, and equipment planning

See ISO 9001:2015 requirements NOTE

(17)

IATF 16949:2016

7.1.4.1 Environment for the operation of processes - supplemental

Blank

8.1.1 Operational planning and control - supplemental 8.1.2 Confidentiality

Blank

8.2.2.1 Determining of requirements related to products and services - supplemental Blank

8.2.3.1.1 Review of requirements related to products and services - supplemental 8.2.3.1.2 Customer-designated special characteristics

8.2.3.1.3 Organization manufacturing feasibility See ISO 9001:2015 requirements

8.2.1.1 Customer communication - supplemental Blank

8.3.1.1 Design and development of products and services - supplemental See ISO 9001:2015 requirements

8.3.2.1 Design and development planning - supplemental 8.3.2.2 Product design skills

8.3.2.3 Development of products with embedded software See ISO 9001:2015 requirements

8.3.3.1 Product design input

8.3.3.2 Manufacturing process design input 8.3.3.3 Special characteristics

(18)

IATF 16949:2016

8.3.5.1 Design and development outputs - supplemental 8.3.5.2 Manufacturing process design output

See ISO 9001:2015 requirements See ISO 9001:2015 requirements See ISO 9001:2015 requirements 8.3.4.1 Monitoring

8.3.4.2 Design and development validation 8.3.4.3 Prototype programme

8.3.4.4 Product approval process

8.3.6.1 Design and development changes - supplemental Blank

See ISO 9001:2015 requirements 8.4.1.1 General - supplemental 8.4.1.2 Supplier selection process

8.4.1.3 Customer directed sources (also know as "Directed-Buy")

8.4.3.1 Information for external providers - supplemental See ISO 9001:2015 requirements

8.4.2.1 Type and extent of control - supplemental 8.4.2.2 Statutory and regulatory requirements

8.4.2.3 Supplier quality management system development

8.4.2.4 Supplier monitoring 8.4.2.4.1 Second-party audits 8.2.4.5 Supplier development

Blank

8.4.2.3.1 Automotive product-related software or automotive products with embedded software

(19)

IATF 16949:2016

8.5.5.1 Feedback of information from service 8.5.5.2 Service agreement with customer See ISO 9001:2015 requirements 8.5.1.1 Control plan

8.5.1.2 Standardized work - operator instructions and visual standards 8.5.1.3 Verification of job setups

8.5.1.4 Verification after shutdown 8.5.1.5 Total productive maintenance

8.5.1.7 Production scheduling

8.5.2.1 Identification and traceability - supplemental See ISO 9001:2015 requirements

See ISO 9001:2015 requirements 8.5.4.1 Preservation - supplemental

Blank

See ISO 9001:2015 requirements 7.1.5.1.1 Measurement systems analysis See ISO 9001:2015 requirements 7.1.5.2.1 Calibration/verification records 7.1.5.3 Laboratory requirements

7.1.5.3.1 Internal laboratory 7.1.5.3.2 External laboratory

See ISO 9001:2015 requirements See ISO 9001:2015 requirements 7.2.1 Competence - supplemental 7.2.2 Competence - on-the-job training 7.2.3 Internal auditor competency

8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment

(20)

IATF 16949:2016

See ISO 9001:2015 requirements 7.3.1 Awareness - supplemental

7.3.2 Employee motivation and empowerment

Blank

9.1.1.1 Monitoring and measurement of manufacturing processes 9.1.1.2 Identification of statistical tools

9.1.1.3 Application of statistical concepts See ISO 9001:2015 requirements

9.1.2.1 Customer satisfaction - supplemental Blank

See ISO 9001:2015 requirements 9.2.2.1 Internal audit programme

9.2.2.2 Quality management system audit 9.2.2.3 Manufacturing process audit 9.2.2.4 Product audit

See ISO 9001:2015 requirements 9.1.3.1 Prioritization

8.6.1 Release of products and services - supplemental 8.6.2 Layout inspection and functional testing

8.6.3 Appearance items

8.6.5 Statutory and regulatory conformity 8.6.6 Acceptance criteria

8.6.4 Verification and acceptance of conformity of externally provided products and services

(21)

IATF 16949:2016

Blank

8.7.1.1 Customer authorization for concession

8.7.1.2 Control of nonconforming product - customer specified process 8.7.1.3 Control of suspect product

8.7.1.4 Control of reworked product 8.7.1.5 Control of repaired product 8.7.1.6 Customer notification

8.7.1.7 nonconforming product disposition See ISO 9001:2015 requirements

See ISO 9001:2015 requirements See ISO 9001:2015 requirements

10.3.1 Continual Improvement - supplemental

Blank

See ISO 9001:2015 requirements 10.2.3 Problem solving

10.2.4 Error-proofing

10.2.5 Warranty management system

10.2.6 Customer complaints and field failure test analysis

See ISO 9001:2015 requirements See ISO 9001:2015 requirements 6.1.2.1 Risk analysis

6.1.2.2 Preventive action 6.1.2.3 Contingency plans ANNEX A: CONTROL PLAN A.1 Phases of the control plan A.2 Elements of the control plan